OnCo
trialsTrialPositive

ASCENT-03

Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.

PFS 9.7 vs 6.9 months (HR 0.62); OS immature at first analysis. Led to 2026 FDA approval of first-line monotherapy. Sets up direct comparison with Dato-DXd (TROPION-Breast02) in the same population.

Setting
First-line metastatic TNBC, not candidates for PD-1 inhibitors: sacituzumab govitecan vs chemotherapy
Phase
Phase 3
Sponsor
Gilead
Registry
Headline result
PFS HR 0.62.
Reported
2025
Enrolled
558
Replication
Consistent with ASCENT (later line) and with TROPION-Breast02 (a different TROP2 ADC in the same first-line PD-1-ineligible population), which strengthens the class effect.

Outcomes

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In plain words
What these results mean for people, not percentages
558 people took part
Progression-free survival (BICR)primarysurrogate endpoint
  • Median 9.7 vs 6.9 months with Sacituzumab govitecan compared with Chemotherapy (TPC); about 2.8 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.5 to 0.77).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Objective response rateresponse endpoint
  • 48 vs 44 out of 100 had their tumour shrink with Sacituzumab govitecan compared with Chemotherapy (TPC); 4 more per 100.
  • Roughly one extra person helped for every 25 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Overall survivalsurvival endpoint
  • Numbers are not recorded here for this endpoint. Sacituzumab govitecan: Immature at the primary analysis; crossover to sacituzumab permitted on progression.; Chemotherapy (TPC).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • Immature at the primary analysis; crossover to sacituzumab permitted on progression.
Be careful
  • These results apply to the people the trial enrolled: First-line metastatic TNBC, not candidates for PD-1 inhibitors: sacituzumab govitecan vs chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

558 participants enrolled.

Progression-free survival (BICR)primary
HR 0.62 (0.5–0.77) · p <0.0001
Sacituzumab govitecan
9.7 mo
Chemotherapy (TPC)
6.9 mo
Source
Objective response rate
Sacituzumab govitecan48 of 100
Chemotherapy (TPC)44 of 100
Overall survival

Immature at the primary analysis; crossover to sacituzumab permitted on progression.

EndpointArmnValueHR (95% CI)pSource
Progression-free survival (BICR)primarySacituzumab govitecan2799.7 months0.62 (0.5–0.77)<0.0001link
Chemotherapy (TPC)2796.9 months
Objective response rateSacituzumab govitecan48%
Chemotherapy (TPC)44%
Overall survivalSacituzumab govitecanImmature at the primary analysis; crossover to sacituzumab permitted on progression.
Chemotherapy (TPC)
Replication
Consistent with ASCENT (later line) and with TROPION-Breast02 (a different TROP2 ADC in the same first-line PD-1-ineligible population), which strengthens the class effect.

Key papers

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Connected

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Pages like this

not linked directly; found by shared links